What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include biologics like Guselkumab (IL-23 inhibitor), 5-aminosalicylic acid (5-ASA) agents, and glucocorticoids. Biologics such as Guselkumab can cause nasopharyngitis, headache, and injection site reactions. 5-ASA agents, including mesalamine and sulfasalazine, may lead to nausea, headache, fever, rash, pancreatitis, and pneumonitis. Glucocorticoids, used for short-term symptom relief, can result in systemic side effects like adrenal suppression, weight gain, hypertension, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several biologic treatments for moderate to severe Ulcerative Colitis. These include anti-TNF agents like infliximab (Remicade) and adalimumab (Humira), which target tumor necrosis factor-alpha (TNF-α). Additionally, vedolizumab (Entyvio), an integrin receptor antagonist, and ustekinumab (Stelara), an interleukin-12 and interleukin-23 inhibitor, have been approved. Ustekinumab is particularly similar to Guselkumab, as both target the IL-23 pathway, although Guselkumab specifically inhibits IL-23. These biologics have shown efficacy in reducing inflammation and maintaining remission in patients with Ulcerative Colitis.

What other types of research exist?

Promising novel alternatives to Guselkumab for Ulcerative Colitis patients include Ustekinumab (an IL-12/23 inhibitor) and Vedolizumab (an integrin receptor antagonist). Both have demonstrated efficacy in treating UC and are viable options for patients seeking alternative treatments.

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Monoclonal Antibodies

Guselkumab for Pediatric Ulcerative Colitis (QUASAR Jr Trial)

Phase 3

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented diagnosis of ulcerative colitis (UC) with a biopsy report supporting the diagnosis available in the source documents

Moderately to severely active UC defined by specific Mayo scores and endoscopy subscores as determined by central review

Must not have

UC limited to the rectum only or less than 20 centimeters of the colon

Presence of a stoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 12 to week 56

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing guselkumab, a medication that reduces inflammation, in children with severe ulcerative colitis who have already shown improvement with earlier treatment. It works by blocking a protein to reduce immune system-related swelling and irritation. Guselkumab has shown benefit in treating inflammatory conditions, with reports of substantial improvement in patients.

Who is the study for?

This trial is for children and teenagers with moderately to severely active ulcerative colitis, a type of inflammatory bowel disease. Participants must have shown some response to earlier treatment phases to qualify.

What is being tested?

The study tests the effectiveness of Guselkumab, a medication, in young patients with ulcerative colitis. It compares Guselkumab against a placebo (a substance with no therapeutic effect) over time.

What are the potential side effects?

Guselkumab may cause side effects like infections, allergic reactions, headaches, stomach pain, and injection site reactions. The severity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed diagnosis of ulcerative colitis with biopsy proof.

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My ulcerative colitis is moderate to severe, confirmed by specific tests.

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I weigh at least 10 kilograms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My ulcerative colitis affects only my rectum or less than 20cm of my colon.

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I have a stoma.

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I have severe inflammation in my colon or have Crohn's Disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 12 to week 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 12 to week 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 12 to week 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants with Clinical Remission at Week 56

Secondary study objectives

European Union: Percentage of Participants With Endoscopic Healing at Week 56

European Union: Percentage of Participants with Endoscopic Healing at Week 12

Number of Participants with Incidence of Anti-guselkumab Antibodies

+18 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Open-label Maintenance Phase: Guselkumab SCExperimental Treatment1 Intervention

Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56.

Group II: Open-label Induction Phase: Guselkumab Subcutaneously (SC)Experimental Treatment1 Intervention

Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase.

Group III: Open-label Induction Phase: Guselkumab Intravenously (IV)Experimental Treatment1 Intervention

Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase.

Group IV: Double-blind Maintenance Phase: Guselkumab Dose Regimen 2Experimental Treatment1 Intervention

At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their BW up to Week 56.

Group V: Double-blind Maintenance Phase: Guselkumab Dose Regimen 1Experimental Treatment1 Intervention

At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their BW up to Week 56.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ulcerative Colitis (UC) include biologic therapies, 5-aminosalicylates (5-ASA), and corticosteroids. Biologic therapies, such as Guselkumab, work by inhibiting specific components of the immune system. Guselkumab targets Interleukin-23 (IL-23), a cytokine involved in inflammatory processes, thereby reducing inflammation and helping to maintain remission in UC patients. Anti-TNF agents like infliximab and adalimumab block tumor necrosis factor-alpha (TNF-α), another key cytokine in inflammation. 5-ASA drugs, such as mesalamine, act locally in the colon to reduce inflammation. Understanding these mechanisms is crucial for UC patients as it helps tailor treatment plans to effectively manage symptoms and maintain long-term remission.